At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 116 enrolled
Drug / intervention
HTX-011 +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty
In Brief
A Phase 3 clinical trial evaluating HTX-011, Ibuprofen, and 4 other interventions for Analgesia. Completed, enrolled 116 participants across 6 sites.
Detailed Summary
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnalgesia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJun 2019
Primary CompletionDec 2020
Study CompletionJan 2021
TodayJul 2026
First PostedJun 5, 2019
Enrollment StartJun 5, 2019
Primary CompletionDec 7, 2020
Study CompletionJan 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago
Interventions
HTX-011drug
Dual-acting local anesthetic. Dose 1.
Ibuprofendrug
NSAID.
Acetaminophendrug
Analgesic.
Celecoxibdrug
NSAID.
+/- Bupivacaine HCldrug
Local anesthetic.
Luer Lock Applicatordevice
Applicator for instillation.
HTX-011drug
Dual-acting local anesthetic. Dose 2.